MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015862
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris pump module smartsite low sorbing infusion set experienced blockage.Verbatim: while pharmacy technician was using tubing 10015862, along with bd phaseal optima products, to circle prime the line.The drip chamber filled with drug, but line would not circle prime.Technician used a syringe to syringe adapter to successfully prime the line with a syringe, but was unable to inject the drug into the smartsite by the drip chamber.The smartsite was blocking all flow.
Additional Manufacturer Narrative
Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation is anticipated but not yet began.Upon completion of the investigation a supplemental report will be filled.
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.It was reported by the customer that the smartsite is blocked.The reported part number does not include a smartsite in its configuration.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 10015862 lot number 22026164 was performed.The search showed that a total of 19,203 units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd alaris pump module smartsite low sorbing infusion set experienced blockage.Verbatim: while pharmacy technician was using tubing 10015862, along with bd phaseal optima products, to circle prime the line.The drip chamber filled with drug, but line would not circle prime.Technician used a syringe to syringe adapter to successfully prime the line with a syringe, but was unable to inject the drug into the smartsite by the drip chamber.The smartsite was blocking all flow.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14142004
• Report Number: 9616066-2022-00416
• Device Sequence Number: 14453302
• Product Code: FPA
• UDI-Device Identifier: 50885403221864
• UDI-Public: 50885403221864
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 10015862
• Device Catalogue Number: 10015862
• Device Lot Number: 22026164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown